Inventory and Evaluation of Clinical Research Networks (NCRR)

Forms and Documents

Document Name	Status
Form 1 IECRN Core Survey-PI Form	Modified
Form 1 IECRN Core Survey-PI/Network Contact Form	New
Cover Memo July 9.doc Supplementary Document	2008-07-09
Attachment 4_NIH Privacy Act Officer.pdf Supplementary Document	2008-07-09
Attachment 3_annual update reminder.pdf Supplementary Document	2008-07-09
Attachment 1_IRB-Exemption.pdf Supplementary Document	2008-07-09
Supporting Statement_Final_July 9_2008.doc Supporting Statement A	2008-07-09

IC Document Collections

IC ID	Document Title	Status
7474	IECRN Core Survey-PI Form	Modified
185785	IECRN Core Survey-PI/Network Contact Form	New

ICR Details

OMB Control No: 0925-0550	ICR Reference No: 200807-0925-001
Status: Historical Active	Previous ICR Reference No: 200506-0925-004
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Inventory and Evaluation of Clinical Research Networks (NCRR)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/17/2008
	Date Received in OIRA: 07/21/2008
Terms of Clearance: Prior terms continue.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2011	36 Months From Approved	11/30/2008
Responses	300	0	275
Time Burden (Hours)	52	0	706
Cost Burden (Dollars)	0	0	0

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Abstract: The Inventory and Evaluation of Clinical Research Networks (IECRN) will help identify the variety, extent, and operating status of existing clinical research networks. Respondents are various members of a clinical research network.

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Authorizing Statute(s): US Code: 42 USC 241(282-b) Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 15530	03/24/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 31874	06/04/2008
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
IECRN Core Survey-PI	1	Survey
IECRN Core Survey-PI/Network Contact	1	Survey

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	300	275	0	25	0	0
Annual Time Burden (Hours)	52	706	0	-654	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The data collection proposed under this clearance request is a revision of a previously approved collection for the Inventory and Evaluation of Clinical Research Networks (IECRN - OMB #0925-0550 Expiration: 07/31/08), a Roadmap project addressing the "re-engineering" of the clinical research enterprise. This request is to continue to use the same instrument (the Core Survey) to collect information from new and newly identified research networks so that the data in the inventory are current and up-to-date. A new component requests that all networks participating in the inventory annually confirm the accuracy of their information so that the data in the inventory remain valid. The in-depth Descriptive Survey component of the previously approved collection is no longer needed, however, as that phase of the project has been completed. Thus, the burden on respondents is significantly reduced.

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Annual Cost to Federal Government: $199,055

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 07/15/2008

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